BAGUERA® C CERVICAL DISC PROSTHESIS
CAUTION: Investigational Device. Limited by Federal (United States FDA) law ONLY to investigational use
PURPOSE OF THE CLINICAL STUDIES
The purpose of the clinical studies is to evaluate the safety and effectiveness of the BAGUERA® C Cervical Disc Prosthesis for patients with neck and/or arm pain, and nerve or spinal cord irritation as a result of the disc(s) in your spine not working properly. The discs are the spongy parts between the bones in your neck, called cervical vertebrae.
BAGUERA® C will be evaluated in two separate Investigational Device Exemption (IDE) clinical studies involving approximately 600 patients for both one and two-level indications.
DESCRIPTION OF THE CLINICAL STUDIES
Each study is a multicenter, prospective, randomized, clinical trial comparing the safety and effectiveness of the BAGUERA® C Cervical Disc Prosthesis to the Mobi-C® Cervical Disc for the treatment of patients with symptomatic cervical disc disease, at a single level or two-contiguous levels, respectively.
There are two groups of patients in this study. The “Investigational” group will receive the BAGUERA® C Cervical Disc Prosthesis, an investigational medical device (not approved by the U.S. Food and Drug Administration). The “Control” group will receive the Mobi-C® Cervical Disc (https://www.cervicaldisc.com), an FDA approved artificial cervical disc.
If you fulfill the eligibility criteria for the study and choose to participate, you will be randomized to receive either the BAGUERA® C or the Mobi-C® Cervical Disc Prosthesis. To be randomized means that you are put into a group indiscriminately. The randomization is done by a computer program. Neither you nor your study doctor can choose the group you will be in and you will not know your treatment assignment until after your surgery. You will have a two out of three chance of receiving the BAGUERA® C device and a one out of three chance of receiving the Mobi-C® device. Additionally, your participation in this study will be for at least 2 years, and up to 10 years, as may be required by the FDA. All subjects will be followed throughout the duration so their outcomes can be monitored and recorded completely.
For more details about the clinical studies, please visit:
The surgical procedure for both study groups requires an incision in the front of your neck followed by your natural disc being removed. Based on the study group you have been randomized to, either the BAGUERA® C device or the Mobi-C® device will be inserted to replace your diseased disc according to the surgical technique requirements for the assigned disc implant.
- Between the ages of 22 and 69.
- Diagnosed with symptomatic cervical disc disease (SCDD) at one or two levels in the neck.
- No adequate response to conservative medical care over a period of at least six weeks.
- Have not had any surgical treatment at any level of the cervical spine.
- Available for regular, scheduled follow-up visits by the treating physician for a minimum of two years.
To determine if you qualify for the study, please contact one of the clinical study sites for information. Do not contact Spineart USA directly.
FIND A CLINICAL STUDY SITE NEAR YOUInsert your ZIP code to see a list of the centers near you participating in the BAGUERA® C Cervical Disc study.
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